For years, many beauty founders assumed FDA attention was something that happened to big manufacturers. Under MoCRA, and with the tools FDA has added since, oversight has more ways in.
Your website is part of the conversation
FDA decides whether a product is a cosmetic or a drug partly by its intended use, and it says that intended use can be established through claims made on labeling, in advertising, on the Internet or in other promotional materials. A product page, a caption or a launch email can all say something your label doesn't.
Your customers don't have to go through you
Customer service isn't the only place a complaint can land. FDA invites consumers to report cosmetic problems directly, online through MedWatch, by mail or fax, or by phone. In September 2025, FDA launched a public dashboard of cosmetic adverse event reports that it says is updated daily and searchable by product name. FDA notes the reports are unverified and aren't a measure of a product's overall safety, but they are public.
Inspections don't come with an invitation
FDA's authority allows inspections of cosmetic establishments at reasonable times and without prior notice. FDA says the factors that can prompt one include the type of products, the significance of consumer or trade complaints received, compliance history, and FDA's own surveillance initiatives.
Records you can be asked for
MoCRA added records access authority. In January 2026, FDA published draft guidance on accessing adverse event records during inspections, and on broader manufacturing and safety records when it reasonably believes a product presents a threat of serious adverse health consequences. Adverse event records are generally kept for six years, or three for qualifying small businesses.
Which raises the questions that matter:
- Does your website make the same claims your label does, and only those?
- If a customer reported a reaction to FDA instead of to you, would you know?
- If someone asked for your records tomorrow, how long would it take to find them?
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Sources
- U.S. Food & Drug Administration, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- U.S. Food & Drug Administration, How to Report a Cosmetic Product Related Complaint
- U.S. Food & Drug Administration, FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
- U.S. Food & Drug Administration, Inspection of Cosmetics
- SafetyCall International, FDA Publishes Draft Guidance on MoCRA Cosmetics Records Access Authority
- U.S. Food & Drug Administration, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
This field note is general information, not legal or regulatory advice for your specific products.